MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-36-54

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that a patient had a right total hip arthroplasty on (b)(6) 2014 and then experienced a surgical revision approximately 9 years, 2 months later on (b)(6) 2024.The patient had a recalled hip liner.Reported event is not related to breakage of a device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.There is no other information available.

Manufacturer Narrative

H10.D10.Concomitants: (b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm; (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6), 186-01-60 - integrip cc, cluster 60mm, g4; (b)(6), 188-01-10 - wedge plasma x/o sz 10.These devices are used for treatment not diagnosis.Pending investigation.

Manufacturer Narrative

H10.Updated/additional information ¿ g1.G2.G4.H6.The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 18563758
• MDR Text Key: 333475367
• Report Number: 1038671-2024-00122
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2019
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male